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临床试验/CTRI/2025/10/096297
CTRI/2025/10/096297尚未招募3 期

Prospective comparative evaluation of the efficacy of preoperative, intraoperative and postoperative administration of antibiotics in Mandibular third molar impaction surgery

The Council of Scientific and Industrial Research1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年11月21日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Post-operative maximal inter-incisal mouth opening

研究概览

简要总结

Wisdom teeth or third molars failing to erupt or erupting partially in oral cavity represent a distinct category of dental conditions named as impacted teeth. Impacted wisdom teeth are extracted because of inflammatory conditions or to prevent future complications. The surgical removal of lower third molars is one of the most frequently performed procedure in oral and maxillofacial surgery1.McGrath et al. concluded that the removal of mandibular third molars resulted in the long-term improvement in the patient’s quality of-life 2.However, the inflammatory process associated with the surgical removal results in various postoperative complications such as pain, swelling, reduced mouth opening(trismus) which are usually managed by antibiotics and analgesics.

 The discovery of antibiotics occurred in 1929 when the Scottish bacteriologist Alexander Fleming, who was working in a London Teaching hospital, reported on the antibacterial action of the cultures of a penicillium species. From there onwards, antibiotics became the greatest contribution of the 20th Century to therapeutics.   Penicillin is the drug of choice in treating odontogenic infections among dental professionals3 as both aerobic and anaerobic microorganisms are susceptible to penicillins4. A combination of penicillin and clavulanic acid is preferred for the treatment of infections caused by staphylococcus, streptococci and pneumococci 4. Clinical trials have validated the use of amoxiclav for chemoprophylaxis in third molar surgery5

There is often a dilemma among oral surgeons concerning the use of antibiotics after the completion of surgical procedure in mandibular third molar impaction surgery. The five principles of antibiotic prophylaxis in the field of maxillofacial surgery have been outlined by Peterson 6. First, the surgical procedure should have a significant risk of infection. Second, the correct antibiotic for the surgical procedure should be chosen. Third, the antibiotic level should be high. Fourth, antibiotic administration must be accurately timed. Fifth, the shortest effective antibiotic exposure should be used. Accordingly, antibiotics should ideally be indicated only when clinical signs of infection are present significantly after a surgical procedure and if the signs and symptoms of infection progress rapidly 5. Evidence has suggested that antibiotics reduces the severity of postoperative pain and infection after the removal of mandibular impacted third molars 7-9, but there have been equally convincing reports that they do not help in prevention of postoperative complications 10-12.

 Third molar extraction procedures are widely acknowledged to be clean contaminated operations 13,14. The degree of impaction appears to have an impact on infection rates, and varying levels of impaction respond to various antibiotic prophylaxis measures, as established by Pieucuch and colleagues 5. According to some publications, the prevalence of postoperative infections following third molar extractions (between 1 and 5%) is too low to warrant routine antibiotic use 15. As a result, there is debate concerning the effectiveness of antibiotics16,17.Antibiotic use is more crucial for immune-compromised patients than in healthy people because they are more likely to develop bacteraemia, which can develop into  septicemia8 .Similarly, uncontrolled diabetic patients and cardiovascular patients also require mandatory antibiotic coverage with invasive dental treatment 9 .Hence, It becomes obvious that special precautions need to be taken in these high risk patients who are more susceptible to infections and that not all healthy patients require prophylactic antibiotics.

However, dental professionals now routinely overprescribe and over administer antibiotics since the prophylactic use of antibiotics has become a common practise even in healthy patients. The development of resistant organisms, secondary infection, toxicity, and the emergence of allergic reactions are among the risks associated with indiscriminate prescription 12 .As per estimates, between 6 and 7 percent of individuals who receive antibiotics experience an adverse reaction 13 .Hence, it is prudent to aim for judicious use of antibiotics as an appropriate method to treat post-surgical infections.

There is a dispute among oral surgeons regarding the route of antibiotic administration. Most practitioners recommend an oral route for antibiotic administration. In contrast, intravenous injection is the most reliable technique to administer therapeutic amounts of antibiotics to the wound in other surgical specialities 14. Halpren and Dodson showed that the use of intravenous antibiotics reduced the incidence of surgical site infections in mandibular third molar impaction surgery 15. The frequency of antibiotic prescription is another contentious issue. According to several authors, administering a single dose of antibiotics at the appropriate time prior to surgery is just as effective as continuing multi-dose therapy for a few days after surgery 16-18. Therefore, the evidence of efficacy of single dose of antibiotics could reduce the risk of resistant strain development and the toxicity associated with antibiotic therapy, in addition to the economic value as a low-cost alternative to the patients.

 The timing of antibiotic further augments the controversy. Since the antibiotic is typically given orally as a post-operative medicine, peak serum levels are only attained a few hours after the tooth is removed. Stone et al. found that surgical wound infections were lowest in those who received preoperative antibiotics in patients undergoing gastric, biliary, and colonic surgery 16. There is ample research in the literature that documents that administering antibiotic prior to surgery may lessen the likelihood of complications following mandibular third molar impaction surgery 19,20. Contrarily, Sekhar et al. have shown that postoperative antibiotic prophylaxis causes fewer complications in mandibular third molar impaction surgery 21.

 In the absence of an international consensus regarding the timing, frequency and route of antibiotic prophylaxis in mandibular third molar impaction surgery, the need for a well-defined clinical trial is obvious. A search of various databases on the successful utilization of the antibiotic prophylaxis in mandibular third molar impaction surgery however has revealed, certain lacunae in the existing literature have been found

 1.     There were significant discrepancies in study settings, case selection, surgical procedures, and surgeon experience, and different protocols for the evaluation of postoperative complications in mandibular third molar impaction surgery.

2.     There are limited studies giving information about the efficacy of single dose administration of 1.2 gm Amoxiclav given intravenously pre-operatively, intraoperatively and postoperatively in mandibular third molar impaction surgery.

3.     There is no clear evidence about the effectiveness of timing of antibiotic administration (preoperative versus intraoperative versus postoperative) in mandibular third molar impaction surgery.

4.     There is no conclusive evidence regarding route of antibiotic administration (oral versus intravenous) in mandibular third molar impaction surgery.

 Hence the aim of this study is:

 1.     To assess the roles of antibiotic prophylaxis on the incidence of postoperative complications in mandibular third molar impaction surgery.

2.     To compare and evaluate the efficacy of single dose intravenous 1.2 gm amoxiclav in reduction of post- operative complications in mandibular third molar impaction surgery when given preoperatively, intraoperatively and postoperatively against routine oral antibiotic practice.

3.     To assess the effects of antibiotic prophylaxis in   mandibular third molar impaction surgery with a specific clinical presentation i.e., in moderately difficult impactions

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)

入选标准

  • above 18 years of age o Radiographic evidence of crown formation and at least 1/3rd root development o Either Male or Female Gender o No antibiotic/anti-inflammatory drugs use for up to two weeks before the planned operation o Impacted mandibular third molar (which require trans alveolar extraction) with Pell Gregory Class I and II and Position A and B o Pederson difficulty index- moderately difficult.

排除标准

  • 1.Patient with history of any systemic illness such as diabetes, cancer, or organ failure including patients who have undergone radiotherapy, immunocompromised patients 2.Patients in which documented Penicillin allergy is present.
  • Pregnancy or lactation or patients taking oral contraceptive drugs.
  • Patients with pericoronitis or acute infection at the time of surgery such as pre-existing abscess or cellulitis characterized by frank purulence, erythema, induration, or trismus.
  • 5.Impacted mandibular third molar with Pell Gregory- Class III and Position Cand Pederson difficulty index i.e., minimally and very difficult impactions 6.Patients who required antibiotics for some other systemic conditions 7.Patients who are active smokers 8.Patients currently on steroid therapy 9.Impacted third molars associated with any periapical cyst or pathology 10.Patients with episodes of diarrhoea after antibiotic therapy or any digestive diseases
  • Patients refusing to participate in the study.

结局指标

主要结局

Post-operative maximal inter-incisal mouth opening

时间窗: 1st, 3rd and 7th post-operative day

次要结局

  • Post-operative inflammatory and infectious symptoms(1st, 3rd and 7th post-operative day)
  • Side Effects of antibiotics(1st, 3rd and 7th post-operative day)
  • Fever(1st, 3rd and 7th post-operative day)
  • Number of rescue analgesics taken(1st, 3rd and 7th post-operative day)

研究者

发起方
The Council of Scientific and Industrial Research
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Anjali Verma

ESIC Dental College and Hospital

研究点 (1)

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